BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERI-STRIPS DRY WITH VERITAS COLLAGEN MATRIX CIRCULAR

    MDR report key: 21036099 · Received December 30, 2024

    Report

    Report Number
    1416980-2024-07661
    Event Type
    Injury
    Date Received
    December 30, 2024
    Date of Event
    October 22, 2024
    Report Date
    January 28, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FTM
    UDI-DI
    00085412531311
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4: LOT #, D4: EXPIRATION DATE, H6 AND H11. D4: LOT #: IT WAS REPORTED THE EXACT LOT NUMBER WAS UNKNOWN; HOWEVER, THE REPORTED EXPIRATION DATE WAS 01/05/2028. THE LOT NUMBERS THAT EXPIRE ON 01/05/2028 ARE SP23I06-1933813 OR SP23K27-1981134. THESE ARE BOTH POTENTIAL LOT NUMBERS. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PERI-STRIPS WITH VERITAS COLLAGEN MATRIX CIRCULAR WAS USED DURING A ROUX-EN-Y SURGERY (GASTRIC BYPASS) AND A PATIENT DEVELOPED TIGHT STRICTURES 3 TO 5 WEEKS POST-OPERATIVELY. THE PATIENT RECEIVED EGD WITH DILATION; HOWEVER, THE STRICTURES APPEAR TO HAVE INCREASED INFLAMMATION AND WERE MORE RESISTANT TO BALLOON DILATION THAN USUAL. THE PATIENT REQUIRED TPN (TOTAL PARENTERAL NUTRITION) VIA A CENTRAL IV LINE AS THEY WERE UNABLE TO EAT BY MOUTH. IT WAS NOT REPORTED IF THE PATIENT REQUIRED PROLONGED HOSPITALIZATION. THE PATIENT OUTCOME WAS ALSO NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2419124 PERI-STRIPS DRY WITH VERITAS COLLAGEN MATRIX CIRCULAR MESH, SURGICAL FTM BAXTER HEALTHCARE CORPORATION PSD25V NI 00085412531311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention